Senior Clinical Research Associate

New Role
- Snr CRA
- Small CRO - US Only

Key Responsibilities

• Independently perform site selection, initiation, routine monitoring, and close-out visits in accordance with the protocol, ICH-GCP, and applicable regulations
• Conduct/oversee remote and on-site monitoring visits, ensuring source data verification, informed consent compliance, and data quality
• Manage a defined caseload of sites with minimal supervision, ensuring enrollment, timelines, and quality metrics are met
• Serve as primary site contact, building strong relationships with investigators and site staff
• Identify and resolve site-level issues, escalating risks to the Clinical Team Lead/PM as appropriate
• Review and ensure completeness of essential documents/TMF in line with ICH-GCP and company SOPs
• Support development of monitoring plans, visit report templates, and site management tools
• Mentor and provide guidance to junior CRAs and CRA-in-training staff
• Contribute to audit/inspection readiness at site and study level
• Liaise directly with sponsors on site status, risk mitigation, and study progress as needed
• Support process improvement initiatives given the CRO's smaller, evolving infrastructure

Requirements

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• Minimum 3–5 years' CRA experience, including independent on-site monitoring (CRO, sponsor, or site-based)
• Strong working knowledge of ICH-GCP, FDA/EMA (or relevant regional) regulations
• Proven track record managing a full monitoring visit caseload independently
• Experience in [therapeutic area, if relevant] preferred
• Excellent communication and site relationship management skills
• Ability to work autonomously in a smaller, less hierarchical company structure
• Willingness to travel 30% for on-site visits (region-dependent)
• Experience mentoring junior staff is a plus